Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K113543 |
Device Name |
ONDEMAND3D |
Applicant |
CYBERMED, INC. |
#504 SJ TECHNOVILLE, |
GASAN-DONG 60-19, GEUMCHEON-GU |
SEOUL,
KR
153-710
|
|
Applicant Contact |
YONG KI IM |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/01/2011 |
Decision Date | 12/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|